Progress Leading to and During the NCI Cancer Center Planning Grant Period. In the more than one decade since the 1995 CCSG application from Emory University, historic changes have taken place in the cancer center and in the institution. In 2000, Dr. Jonathan Simons was recruited from The Johns Hopkins Oncology Center to serve as Emory's Cancer Center Director. Dr. Simons designated the name "Winship Cancer Institute" and this entity incorporated all cancer care and research at Emory University and its clinical affiliates. The entire Section of Hematology and Medical Oncology was moved institutionally from the Department of Medicine into the WCI, adding a new and significant capacity of faculty/investigators to the WCI as a department. Dr. Fadlo Khuri was recruited from the University of Texas MD Anderson Cancer Center to lead the section of hematology and medical oncology and to expand its faculty and clinical and translational enterprise. Drs. Khuri and Simons jointly recruited faculty whose primary appointments were to be in the Section. Dr. Simons jointly reported to the Dean of the Emory School of Medicine (SOM) and the Executive Vice President for Health Affairs and represented the WCI at the SOM's Council of Chairs. The physical facility changed dramatically from the initial space in Emory Clinic Building B, which now houses some shared core resources, laboratories, clinical, and administrative space. Beginning in 1998, with strong support from the Woodruff Foundation, the Woodruff Health Sciences Center, and the School of Medicine, an entire new cancer center building was constructed and was dedicated in 2001 as the Winship Cancer Institute. This five-story building of more than 175,000 nsf contains research laboratories;multiple shared core resources, including Clinical Research;clinical space for Medical Oncology, Hematology Oncology, Radiation Oncology, Surgical Oncology, Radiology and Breast Imaging;and Cancer Center Administration. In 2002 a new Cancer Center Planning Grant (P20) was funded to support an intensive effort toward designation as an NCI cancer center at Emory. Over the previous Planning Grant period, the Winship Cancer Institute has developed as a matrix cancer center that promotes and supports interactions among a diverse group of individuals from numerous Emory units and departments. The P20 planning grant process has been utilized to develop strategies that facilitate the achievement of our stated goals and objectives. These strategies have been applied to the rapid translation of basic science to "proof of concept" investigations, including cohort-based, population-based testing in Atlanta and Georgia. Such translational projects range from development of genomic assays and biomarkers to longitudinal investigations of populations at increased lifetime risk of cancer. During the five years since the P20 Planning Grant was funded, the Winship Cancer Institute has made significant progress towards developing an NCI-designated Cancer Center at Emory University. Over the past five years, 88 key cancer center members were recruited. These 88 members have appointments in 19 academic departments within the Schools of Medicine. Public Health and Nursing and Emory College. Significant intra- and interprogrammatic research has emerged in publications, new investigator-initiated and team science grants, and novel translational investigations, particularly in biomarker and drug development and cancer control. In addition, efforts continue actively and aggressively toward recruitment of additional basic, .translational, clinical, and cancer control scientists to further enhance the quality and depth of our scientific programs. Further growth of the already strong cadre of cancer investigators is anticipated to accelerate both the number and pace of basic science discoveries and clinical trials, and our ability to disseminate these discoveries into the community at-large. These accomplishments will significantly impact our research and clinical missions over short-term and long-term strategic timelines. Considerable,progress was accomplished during the five years of the Planning Grant period. [unreadable] Many of the scientific achievements are described in the programs and shared core resources. However, developments that are significantly pertinent to the P20 period are introduced here: 1) Recruitment of a new Cancer Center Director; 2) Reconfiguration of the scientific programs in the Cancer Center from the previous organ-sitespecific focus to cross-cutting themes; 3) Growth of cancer-focused team science initiatives at Emory University; 4) Continued progress of thematic focus areas of research. Recruitment of New Cancer Center Director. An important event during the P20 period was the recruitment of a new Director of the Cancer Center. Dr. Simons departed from Emory in 2006, and the role of WCI Director was filled by Dr. Paul Doetsch, who served as Interim Director. After an international search, Brian Leyland-Jones, MD, PhD was recruited in 2007 to serve as Director of the WCI. Since Dr. Leyland-Jones'arrival at Emory, the completion of the P20 and plans for pursuit of the P30 grant have been solidified and implemented. Dr. Leyland-Jones serves as PI for the CCSG. Upon his recruitment in January 2007, Brian Leyland-Jones, MD, PhD assumed the positions of both Cancer Center Director and Associate Vice-President for the Woodruff Health Sciences Center. This latter additional title in the WHSC served to reinforce the role of the cancer center and its Director as the central focus for all cancer research and activities at Emory University at the institutional level, and to strengthen the authority of the Director across the University. Shortly after he began his position at Emory, Dr. Leyland-Jones and other key leadership traveled to the NCI and met with Center Branch staff to review the key goals to be accomplished prior to submission of the P30 grant proposal. In addition, the plan to submit the P30 application for the May 25, 2008 deadline was confirmed. - With WCI Leadership, Dr.'Leyland-Jones has led the efforts to: 1) reorganize the Clinical Trials Office to better assign priorities and increase efficiencies;2) plan and develop new initiatives directed toward predictive oncology and biomarker development;3) consolidate and enhance the shared core resources;and 4) reconfigure the scientific programs as outlined below. Reconfiguration of the Scientific Programs. As part of its on-going, scheduled evaluation of the Winship Cancer Institute, the WCI's External Advisory Board (EAB) met in June 2007 to review progress toward the Cancer Center Support Grant. This was the first time the EAB had met since the recruitment of Dr. Leyland-Jones six months prior to that date. The EAB feedback given at the time of this meeting, combined with input from other WCI leadership, WCI members, NCI Cancer Centers'Branch staff, and with Dr. Leyland-Jones'vision for the center, were carefully reviewed. The organ-based programs active at that time were evaluated along with more cross-cutting themes. Subsequently, Dr. Leyland-Jones sought additional feedback from EAB members and from the senior leadership of the WCI regarding scientific programs and shared cores, including optimal number and guiding principles for determination of research foci. Additionally, objective data regarding accruals to organ site-specific clinical trials, grant funding, and membership related to each current program were carefully reviewed. As a result of extensive input from outside resources and with significant participation from WCI leadership internally, in October 2007, Dr. Leyland-Jones presented'a new plan for reconfiguration of the WCI scientific programs. Reasons for the program reconfiguration were based on: 1) Consultation with NCI Cancer Centers Branch (September 2007) and WCI Leadership; 2) Feedback from EAB and other Cancer Center directors nationally; 3) Emphasis on translational research, including trial accrual, for organ-site specific programs; 4) Criteria for evaluation for each scientific program area, including distribution of extramural funding and program membership. Guiding principles used for program reconfiguration were: a) relevant over-arching scientific themes;b) thematic focus to highlight what may be unique contribution by WCI as an NCI designated cancer center;c) opportunities for intra- and inter-programmatic interactions. In October 2007, it was proposed by Dr. Leyland-Jones that Cancer Control and Population Science (CCPS) and Cancer Genetics and Epigenetics (CGE) be kept as primary programs, while the other two programs would be modified along the lines of cross-cutting thematic areas rather than organ sites. Reconfiguration reflected the guiding principles with careful attention given to distribution of members and grant funding. As a result of these considerations, two newly-reconfigured program areas plus CGE and CCPS were established as listed below: 1) Cancer Genetics and Epigenetics (CGE): Paul Doetsch, PhD (Program Leader), Paula Vertino, PhD, John Petros, MD (Co-Program Leaders); 2) Molecular Pathways and Biomarkers (MPB): Erwin van Meir, PhD (Program Leader), Leland Chung, PhD, Mark Goodman, PhD, Ruth O'Regan, MD (Co-Program Leaders) 3) Discovery and Developmental Therapeutics (DDT): Fadlo Khuri, MD (Program Leader), Haian Fu, PhD, Dong Shin, MD (Co-Program Leaders) 4) Cancer Control and Population Sciences (CCPS): Robin Bostick, MD (Program Leader), Andrew Miller, MD, Joseph Lipscomb, PhD, Karen Glanz, PhD (Co-Program Leaders). Importantly, it should be noted that although the program names and specific focus areas were changed from an organ site orientation to a more over-arching scientific thematic approach, the program members and interactions in most cases were not affected by the reconfiguration. Two of the programs -CGE and CCPS -were essentially unchanged by the program reconfiguration. The revamping of the prior organ site focus mainly involved the MPB and the DDT programs. The programs'reorganization in order to address these more inclusive themes has allowed WCI members engaged in outstanding translational and clinical research that may not have been specifically focused in one organ site, to pursue greater involvement in these programs and thus also generate more collaborations and interactions with other WCI members. The overall result of the program reconfiguration has been extremely positive, allowing for greater trans- and multi-disciplinary interactions between and across investigators, regardless of the specific tumor focus of their research. The EAB at their November 2007 meeting expressed strong enthusiasm for the program reconfiguration as presented. In addition, the Shared Core Resources were also reorganized by Dr. Leyland-Jones along with WCI Leadership and Core Resource Directors to provide greater efficiency of services. In particular, the Microarray, Genomics, and Proteomics cores were all consolidated into one CLIA-compliant core, termed Biomarker Profile Core (BPC).